IMPLANT PROBLEMS

Almost all breast implants used in the United States have a 10-year warranty. While some implants can last for decades, many implants need to be changed in a much shorter period of time. Implants are not expected to last forever. According to data gathered by the implant manufacturers, about half of breast implants need to be changed within seven years. The most common reasons for implant problems include capsular contracture, rupture, and infection.

Capsular Contracture

Capsular contracture is scarring that occurs around the breast implant. All breast implants - smooth, textured, round, shaped, above muscle, below muscle - will develop a capsule. Since implants are a foreign body, the body tries to wall off the implant by creating a capsule around it as a barrier from the implant. The capsule can be something that is soft and flimsy - almost like a film that is not noticeable. Or it can become firm and painful - almost like a hard shell that feels like it shrinks and contracts over time. When an implant develops a hard, painful capsular contracture, it is not dangerous in and of itself. The discomfort, however, may lead women to want the implant and the capsule removed in its entireity. 

An en bloc capsulectomy can be performed to remove the implant and the capsule in one piece. A complete en bloc capsulectomy is a painstaking and meticulous procedure that removes every bit of the capsule, including the section that may be very adherent to the chest wall and ribs. A partial capsulectomy leaves pieces of the capsule in the breast pocket. The surgical dissection from an en bloccapsulectomy is an irritant to the remaining breast tissue, and will stimulate fluid production from the body. After an en bloc capsulectomy, it is usually necessary to place drains to allow the fluid from the breast pocket to exit the body. If a new implant is being placed, it usually placed in a fresh space. In other words, if the original implant was placed subpectorally, the new implant would be placed prepectorally. Conversely, if the original implant was placed prepectorally, the new implant would be placed subpectorally. Sometimes, the pectoralis muscle has been divided or damaged. In these cases, it is necessary to repair the pectoralis muscle.

For patients who undergo implant removal and en bloc capsulectomy and do not want an implant replaced, drains will need to be left to drain fluid in for a longer period of time. The body does not like empty spaces, and will try to fill the potential space with fluid. For patients who still have breast tissue, they may need a breast lift, or mastopexy, to rearrange any remaining breast tissue to recreate a breast mound. Otherwise, the stretched-out breast skin that has lost the volume from the implant may look empty, deflated, and unsightly. Some patients who do not want implants but need more volume may benefit from fat grafting to add bulk to their breast tissue. Fat grafting involves liposuction from another part of the body, processing and purifying the lipoaspirate, and then injecting the purified fat cells into the breast tissue to add volume.

For patients who have no breast tissue after implant removal and en bloc capsulectomies because they have undergone mastectomies, they can decide to undergo a new breast reconstruction with implants or with their owntissue. Autologous tissue breast reconstruction after mastectomy is best performed with flaps, in which skin and fat from another part of the body is transferred to the chest with its own blood supply to create a new breast. The gold standard in autologous tissue breast reconstruction is perforator flaps.

Rupture

Both saline and silicone implants can rupture. All implants - even saline implants - have a silicone shell, and the silicone shell can wear out over time. When a saline implants ruptures, it is quite obvious as the implant simply deflates. In addition, the saline that spills into the tissues should be safe, as saline is the same fluid that is used intravenously to rehydrate the body. When a silicone implant ruptures, however, it may be silent. Furthermore, silicone is supposed to be inert, but the ruptured silicone gel can cause irritation and inflammation to the surrounding breast tissue that can worsen over time. 

Both ruptured saline and silicone breast implants should be removed and/or replaced. In the operating room, removing a ruptured saline implant is relatively straightforward. Removing a ruptured silicone implant, however, is more challenging because the thick sticky gel can be difficult to remove. If the silicone gel spills into the tissues, it may be necessary to resect some breast tissue. This can leave breasts appearing dimpled, wrinkled, sagging, and otherwise deformed, and the remaining breast tissue may not return to its original shape. If a ruptured silicone implant is replaced, there may be a higher risk of complications compared to the first time. If an implant is not replaced, it may be necessary to perform other procedures to recreate a breast shape.

Infection

Since breast implants are a foreign body, they do not have a blood supply. If a patient develops breast infection, the implant cannot bring white blood cells and other natural defenders of the body to fight the infection. If the infection is a skin infection only, such as redness from cellulitis, then it may be possible to control the infection with antibiotics. If a breast implant itself becomes infected, however, because bacteria is seeded on the implant, then it needs to be removed. 

Extrusion

Since breast implants are a foreign body, they can create pressure against the breast skin from the inside. This constant pressure occasionally leads to erosion of the breast skin so that implant starts to push through the skin. When the breast implant pushes through the skin to the outside world, this is called extrusion. Although rare, extrusion is most common among women who have undergone radiation treatment for cancer. This is because radiation therapy damages the skin, and makes it more difficult to heal. Extrusion can also occur in breasts that have not undergone radiation if the patient or her skin has been otherwise compromised.

Anaplastic Large Cell Lymphoma

In 2011, the FDA identified a possible association between breast implants and anaplastic large cell lymphoma (ALCL). In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. BIA-ALCL is a rare type of non-Hodgkin lymphoma (a cancer involving the cells of the immune system) found in the scar tissue and fluid near an implant that can sometimes spread throughout the body. Most data suggest that BIA-ALCL occurs more frequently with breast implants that have textured surfaces rather than smooth surfaces.

As of 30 September 2017, the FDA had received 414 medical device reports of BIA-ALCL, including the death of 9 patients. Only 272 of the 414 reports included information on the implant surface, including BIA-ALCL found associated with 242 implants with textured surfaces and 30 implants with smooth surfaces. Of these, 234 reported implants associated with BIA-ALCL were filled with silicone gel and 179 reported implants were filled with saline. About half of the reported cases were diagnosed within 7-8 years of breast implantation. Several recent journal articles explore risk factors for developing BIA-ALCL, including the role of biofilm. Treatment includes removal of the implant and capsule surrounding the implant and, in some patients, treatment with chemotherapy and radiation. Current literature estimates that BIA-ALCL may develop in 1 in 3,817 to 30,000 women with textured breast implants.

ALCL is very rare, but women with breast implants may have a very slightly increased risk of developing ALCL in the scar capsule surrounding the breast implant. There is currently no trend of implant type (saline vs silicone) or implant reason (aesthetic augmentation vs reconstruction) associated with a smaller or greater risk of ALCL. Textured implants may be at slightly greater risk for ALCL than smooth implants, but findings are not conclusive. When ALCL occurs with breast implants, it is identified most frequently in patients undergoing implant revisions for late onset, persistent seroma (a fluid collection that develops around the implant), or other symptoms such as pain, lumps, swelling, or breast asymmetry. The FDA does not currently recommend prophylactic breast implant removal in patients without symptoms or other abnormalities. Since the risk of ALCL considered to be small and inconclusive, breast implants are still approved in the USA when used as labeled for breast augmentation or breast reconstruction.